Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients (MAPS)

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device

To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Arrhythmia Management System (AMS)

Detailed Description

The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.

• Study Type: Observational
• Enrollment (Actual): 585

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Cardiovascular Medical Group
    • Long Beach, California, United States, 90813
      • Cardiovascular Innovation and Research Center
    • Los Angeles, California, United States, 90027
      • Heartbeat Cardiovascular Medical Group
    • West Hills, California, United States, 91307
      • Interventional Cardiology Group
  • Florida
    • Jacksonville, Florida, United States, 32086
      • Flagler Hospital/Flagler Health
    • Ocala, Florida, United States, 34476
      • Cardiovascular Institute of Central Florida
    • Saint Augustine, Florida, United States, 32086
      • First Coast Heart and Vascular Center
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • New York
    • Cheektowaga, New York, United States, 14227
      • Trinity Medical
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
  • Texas
    • Amarillo, Texas, United States, 79109
      • ClinicalTex Research LLC d/b/a PharmaTex Research
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • McKinney, Texas, United States, 75070
      • Heart Rhythm Specialists
    • McKinney, Texas, United States, 75071
      • Cardiovoyage
    • Pasadena, Texas, United States, 77505
      • Orion Medical Research
  • Washington
    • Burien, Washington, United States, 98166
      • Daniel W. Gottlieb, Md, Ps
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects, 21 years or older who:

1. Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias
2. Are without any cardiac implantable electronic devices, including loop recorders
3. Are without wearable cardioverter defibrillator
4. Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
5. Are not currently hospitalized
6. Do not have any skin condition that would prevent them from wearing the AMS device
7. Are not non-ambulatory
8. Are not reporting to be pregnant
9. Are not participating in another clinical study

Description

Inclusion Criteria:

• Subjects who require monitoring for non-lethal cardiac arrhythmias
• Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
• Subjects 21 years of age or older

Exclusion Criteria:

• Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
• Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
• Subjects currently hospitalized
• Subjects with a skin condition preventing them from wearing the AMS device
• Subjects who are non-ambulatory
• Subjects who are self-reporting to be pregnant
• Subjects participating in another study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients indicated for Mobile Cardiac Telemetry Monitoring; Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner.	Device: Arrhythmia Management System (AMS); AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biometric Data Associations to Arrhythmias	MCT Data Sets	30 days
Biometric Data Associations to Subject-Reported Symptoms	MCT Data Sets	30 days
Biometric Data Associations to Subject Wellness	MCT Data Sets	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Use of Biometric Data Associations to Arrhythmias	Clinical Case Report Forms	30 days
Clinician Use of Biometric Data Associations to Subject-Reported Symptoms	Clinical Case Report Forms	30 days
Clinician Use of Biometric Data Associations to Wellness Status of Subject	Clinical Case Report Forms	30 days

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Chair: Ramu Perumal, PhD, Zoll Services LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cardiac; arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 90D0234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No